Actively Recruiting
CHOP Plus Mosunetuzumab as First Line Treatment in Patients With Richter's Syndrome: Phase II Study by the Spanish Group of CLL
Led by GELLC (Grupo Español de Leucemia Linfocítica Crónica) · Updated on 2025-04-13
34
Participants Needed
16
Research Sites
N/A
Total Duration
On this page
Sponsors
G
GELLC (Grupo Español de Leucemia Linfocítica Crónica)
Lead Sponsor
E
Evidenze CRO
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate if the drug Mosunetuzumab works to treat Richter's Syndrome and to understand its safety. It focuses on patients with Richter's Syndrome who have never received therapy before. This Phase II clinical trial is sponsored by the Spanish Group of Chronic Lymphocytic Leukemia (GELLC) and seeks to assess the effectiveness of Mosunetuzumab combined with CHOP chemotherapy. Participants will receive six cycles of Mosunetuzumab combined with CHOP chemotherapy. After these induction cycles, patients who have stable disease or a partial or complete response but are not candidates for cellular therapy will continue treatment with Mosunetuzumab alone for eleven additional 21-day cycles, lasting about ten months. This treatment continues until disease progression or unacceptable side effects occur. During the study, participants will visit the clinic every 2 to 3 weeks for checkups and tests. Researchers will monitor how well the treatment works after the induction and maintenance phases, track any side effects, and evaluate how long patients stay on treatment. The total treatment period can last up to approximately 16 months, and safety and effectiveness will be carefully assessed throughout.
CONDITIONS
Brief Title
CHOP Plus Mosunetuzumab as First Line in Patients With Richter´s Syndrome: a Phase II Study of the Spanish Group of CLL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent
- Aged between 18 and 79 years
- Able to comply with study procedures and hospital visits
- ECOG performance status of 0, 1, or 2
- Adult patients with untreated, histologically confirmed Richter's Syndrome, diffuse large B cell variants
- Evidence of CD20 positive disease by flow cytometry or immunohistochemistry
- Adequate bone marrow function with platelet count ≥75 x 10^9/L (or ≥30 x 10^9/L if due to marrow involvement), ANC ≥1 x 10^9/L unless due to marrow involvement, hemoglobin ≥9 g/dL unless due to marrow involvement
- Creatinine clearance ≥45 mL/min
- Life expectancy greater than 3 months
- Women of childbearing potential must agree to use effective contraception or abstain during treatment and for specified periods after
- Men must agree to use condoms or abstain during treatment and for specified periods after
You will not qualify if you...
- Pregnant, breastfeeding, or intending to become pregnant during the study or within 3 months after last dose
- Prior treatment with Mosunetuzumab or other CD20/CD3 bispecific antibodies
- Recent autologous stem cell transplant within 100 days
- Prior allogeneic stem cell transplant or recent CAR T-cell therapy within 100 days
- Systemic corticosteroid treatment >20 mg/day prednisone or equivalent within 5 days before treatment start
- Central nervous system involvement
- Transformation of CLL to prolymphocytic leukemia
- History of certain prior malignancies unless recovered for ≥2 years
- Laboratory abnormalities including low creatinine clearance, low neutrophils or platelets, elevated liver enzymes or bilirubin
- Severe allergic reactions to monoclonal antibodies
- Contraindication to tocilizumab
- Active autoimmune disorders
- History of autoimmune diseases except some controlled conditions
- History of solid organ transplant
- Active infections requiring IV antibiotics or hospitalization within last 4 weeks
- History of progressive multifocal leukoencephalopathy
- Positive HIV or active hepatitis B or C infection
- Chronic active Epstein Barr Virus infection
- History of macrophage activation syndrome or hemophagocytic lymphohistiocytosis
- Recent live attenuated vaccine within 4 weeks or anticipated during study
- Left ventricular ejection fraction <50%
- Significant cardiovascular, pulmonary, liver, or CNS diseases
- Recent major surgery within 4 weeks
- Dependence on sponsor or investigator
- Any serious medical condition or lab abnormality precluding safe participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive 6 cycles of Mosunetuzumab combined with CHOP as first line treatment.
6 treatment cycles with associated visits
Duration - Up to eleven 21-day cycles (approximately 10 months) or until disease progression or unacceptable toxicity
Participants who achieve stable disease or partial/complete response and are not candidates for cellular therapy receive mosunetuzumab monotherapy.
11 treatment cycles with associated visits
Trial Site Locations
Total: 16 locations
1
Hospital Vall Hebron
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
2
Hospital Clínic y Porvincial de Barcelona
Barcelona, Barcelona, Spain, 08036
Actively Recruiting
3
ICO Hospitalet Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Actively Recruiting
4
H Marqués de Valdecilla
Santander, Cantabria, Spain, 39011
Actively Recruiting
5
Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain, 35010
Active, Not Recruiting
6
Hospital Universitario La Princesa
Madrid, Madrid, Spain, 28006
Actively Recruiting
7
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain, 28041
Actively Recruiting
8
Hospital General Universitario Morales Meseguer
Murcia, Murcia, Spain, 30008
Active, Not Recruiting
9
Hospital Universitario Costa del Sol
Marbella, Málaga, Spain, 29603
Active, Not Recruiting
10
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
11
Hospital Universitario de Salamanca
Salamanca, Salamanca, Spain, 37007
Active, Not Recruiting
12
Hospital de Donostia
Donostia / San Sebastian, San Sebastian, Spain, 20014
Actively Recruiting
13
Centro Hospitalario Universitario de Santiago
Santiago de Compostela, Santiago de Compostela, Spain, 15706
Actively Recruiting
14
Hospital Universitario Virgen del Rocío
Seville, Sevilla, Spain, 41013
Active, Not Recruiting
15
Hospital Universitario Clínico de Valencia
Valencia, Valencia, Spain, 46010
Active, Not Recruiting
16
Hospital Universitario Lozano Blesa
Zaragoza, Zaragoza, Spain, 50009
Active, Not Recruiting
Research Team
A
Ana Méndez, Sponsor representative
T
Teresa Pascual Tome, CRO representative
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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